SEP-1: Guiding Lifesaving Care

“SEP-1” is shorthand for “The Severe Sepsis and Septic Shock Early Management Bundle.” It lays out a process for healthcare professionals in hospitals to follow. The process includes key steps and milestones in early sepsis care that are to be completed in a specific time frame. SEP-1 is a standardized process, which means that it should be followed for every patient with severe sepsis or septic shock in the same way, every time. 

Hospitals that participate in caring for patients with Medicare and Medicaid insurance coverage report how well they achieve these SEP-1 milestones to the Centers for Medicare and Medicaid Services (CMS). 

SEP-1 was developed by Emanuel Rivers, MD, of Henry Ford Hospital and Sean Townsend, MD, of California Pacific Medical Center – Sutter Health. It was first approved by the National Quality Forum in 2008 and adopted by CMS in 2015. Both Dr. Rivers and Dr. Townsend serve as current members of the Sepsis Alliance Advisory Board.

SEP-1 focuses on timely sepsis recognition and early intervention with lifesaving therapies, like a fast first dose of broad-spectrum antibiotics. These act against many types of bacteria, rather than just a few. The emphasis on timing is critically important. Saving lives and limbs from sepsis is all about time. Each hour of delay before a patient with severe sepsis and septic shock is treated is associated with a 4 to 9% increased risk of mortality.

In 2015, CMS began using SEP-1 to guide sepsis management. Since then, any hospital receiving reimbursement from Medicare or Medicaid—which is most hospitals—must measure and report on how well their institution is complying with SEP-1. 

This is a good thing for patients with sepsis because: 

• Having a standard process for every patient with sepsis encourages closing gaps in sepsis outcomes across race, socioeconomic status, geography, and insurance status. 
• Encouraging hospitals to report on their sepsis processes helps ensure that hospital leadership and clinicians are keeping their focus on the possibility of sepsis in every case. 
• Providing incentives for hospitals to report how well they comply with SEP-1 helps ensure that they follow evidence-based guidelines that benefit patients.  

Despite all these benefits, some groups are opposed to SEP-1. Below are some arguments made against SEP-1 along with Sepsis Alliance’s rebuttals. 

The Argument: Opponents argue that SEP-1’s quick treatment with antimicrobials contributes to the growing problem of antimicrobial resistance (AMR). AMR occurs when specific strains of bacteria, viruses, fungi, or parasites adapt in order to avoid medicines designed to treat them. SEP-1’s opponents argue that when clinicians are encouraged to administer drugs very quickly, they don’t have time to correctly identify which drugs, if any, are needed, therefore contributing to overuse and resistance.  

Our Response: SEP-1 only dictates when a first dose of antimicrobials should be given. By the time a second dose might be appropriate, clinicians usually have had time to get a more complete picture of the patient and can adjust the course of treatment as necessary. This discourages antimicrobial overuse and resistance while still encouraging clinicians to give drugs quickly to patients who may desperately need them. 

The Argument: Opponents argue that early antimicrobials save more patients with septic shock than patients with sepsis—and that, therefore, early treatment is not necessary for everyone. 

Our Response: A larger fraction of septic shock patients can be saved by early antibiotics, but that is simply because patients are more likely to die once they have progressed to septic shock. Studies show that early antibiotics for patients with infection or sepsis can prevent those patients from progressing to septic shock and can save lives.    

The Argument: Opponents argue that the process is tricky to implement in hospitals because it has many steps and requires extra personnel to track those steps. 

Our Response: Many who argue that SEP-1 is tricky to implement may be responding to difficulty diagnosing sepsis. The SEP-1 treatment steps need to be achieved within a short window of time once sepsis is suspected, and sepsis diagnosis can be complex. With training, diagnosing sepsis becomes easier and the timing of treatments improves. Processes like SEP-1 also become easier to implement over time as they become a routine part of hospital operations. Studies show that as hospitals assign personnel and develop procedures, these processes become increasingly able to “serve as a focus for improvement strategies.” 

The Argument: Opponents argue that not all sepsis patients need the amount (30mL/kg) of intravenous fluid recommended by SEP-1. 

Our Response: We know that not all patients with sepsis need this amount of IV fluid for resuscitation, and there are acceptable ways to determine which patients need that volume of fluid and which do not. SEP-1 merely requires that providers document their clinical reasoning if they choose to administer less than the recommended amount; it does not require that every patient receives that quantity of IV fluid. Having a standard operating procedure—including what to do when there is a reason not to follow a recommendation—ensures the best care for the most people. 

The Argument: Opponents argue that SEP-1 encourages diagnosing sepsis in patients who are not severely ill, and that the reduction in mortality shown in studies is simply due to treating less sick patients earlier. 

Our Response: SEP-1 does encourage diagnosing sepsis in patients who are less ill. As people who could some day be patients with sepsis, we find it hard to see what is wrong with encouraging intervention before things get worse. That philosophy applies to any disease, but it is very poignant when applied to sepsis, the leading cost of care and cause of death in U.S. hospitals. 

Since the 2000s, SEP-1 has been approved by both CMS and the Nation Quality Forum. NQF, an organization that works to ensure patient protections and overall healthcare quality, first endorsed SEP-1 back in 2008 and has re-endorsed it in regular review processes every three years since. However, in recent years some groups have lobbied NQF to consider removing SEP-1’s endorsement, and in early 2022, these opponents submitted an official appeal of NQF’s endorsement of SEP-1.  

In April 2022, NQF voted to dismiss that appeal. This decision will help to keep sepsis at the forefront of clinical discourse, where it belongs, and will help to pave the way for future progress. But SEP-1 may come up in these conversations again. NQF may vote differently in the future. That’s why Sepsis Alliance continues to emphasize that SEP-1 needs to be protected. 

A study by Dr. Townsend and Dr. Rivers, two of SEP-1’s original authors, further supports SEP-1. The 2021 study, “Effects of Compliance with the Early Management Bundle (SEP-1) on Mortality Changes Among Medicare Beneficiaries with Sepsis,” examined patient-level data reported to Medicare by 3,241 hospitals between 2015 and 2017. The study shows that, in hospitals that follow SEP-1 guidelines, there is a lower percentage of patients who die in the first 30 days after a sepsis hospitalization.  In fact, SEP-1 compliance lowers mortality by approximately 4%, from 26.3% to 22.2%, which translates to between 14,000 and 15,000 fewer patients dying from sepsis per year. 

Read the full study, published by the American College of Chest Physicians: Effects of Compliance with the Early Management Bundle (SEP-1) on Mortality Changes Among Medicare Beneficiaries with Sepsis.

Other SEP-1-related studies and articles:

• Patients need Sep-1: Why don’t some doctors like it? (pg. 15)
• The Value of SEP-1
• Time to Treatment and Mortality During Mandated Emergency Care for Sepsis 
• Towards Understanding the Effective Use of Antibiotics for Sepsis
• Antibiotic Timing and Progression to Septic Shock Among Patients in the ED With Suspected Infection
• Temporal Trends in Antimicrobial Prescribing During Hospitalization for Potential Infection and Sepsis
• Early Infectious Disease Consultation Is Associated With Lower Mortality in Patients With Severe Sepsis or Septic Shock Who Complete the 3-Hour Sepsis Treatment Bundle.

• Read Sepsis Alliance’s letter of support for SEP-1 here.
• Read our op-ed on the history and necessity of SEP-1 here. 
• Listen to patient advocate Katy Grainger, a sepsis survivor and multiple amputee, tell her story to an NQF Committee after it voted in favor of the measure in 2021: